The revised Provisions for the Environmental Administration of New Chemical Substances (MEP Order 7), unofficially known as "China REACH", was released by the Chinese Ministry of Environmental Protection (MEP) and came into force on 15 October 2010. These Provisions impose highly demanding and complex notification requirements on companies wishing to place chemicals on the Chinese market.
MEP Order 7 requires manufacturers and importers of a "new substance" to submit a new chemical substance notification (NCSN) to the MEP's Solid Waste and Chemical Management Centre (MEP-SCC). A new substance is defined as a chemical that is not listed on the Inventory of Existing Chemical Substances in China (IECSC), excluding substances subject to exemptions.
Companies must obtain a Registration Certificate from the MEP-SCC prior to production and/or import of new substances into mainland China. Foreign companies cannot notify directly and must appoint a representative agent to carry out the notification on their behalf.
There are three main notification types under MEP Order 7: Regular notification; Simplified notification and Scientific research record notification.
An overview of the notification procedure under MEP Order 7 is shown below.
The Regulations on Safe Management of Hazardous Chemicals (Decree 591) came into force in 2011 and is the overarching law on the control of hazardous chemicals in China. Decree 591 is supported by a number of catalogues and ministerial regulations that help to manage hazardous chemicals across the supply chain.
A number of different chemical inventories help to implement Decree 591. The most important of these is the "Catalogue of Hazardous Chemicals". Chemicals on this Catalogue are subject to registration and licensing requirements.
Chinese manufacturers and importers of hazardous substances (and mixtures containing them) are likely to have to register their chemicals with the Chinese authorities under SAWS Order 53. The registration certificate is valid for 3 years and can be renewed. Unlike China NCSN, there is no tonnage threshold for the registration.
Depending on their role in the supply chain, companies handling hazardous chemicals may also require production, operating, transport or safe use licences.
China implements the 4th revised edition of UN Globally Harmonised System of Classification and Labelling of Chemicals (GHS). GHS Article 15 of Decree 591 states that all hazardous chemicals are required to comply with national standards on labelling and Safety Data Sheet (SDS) provision. In addition, MEP Order 7 states that new substances require SDS and labels. China GHS is enacted through a number of mandatory (GB) and recommended (GB/T) standards.
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